Evaluating and Treating Potential Research Participants With Digestive Disorders

NCT ID: NCT01736280

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-17
• Study Completion Date: 2019-11-21

Brief Summary

Background:

• Some research studies focus on digestive disorders, such as nutritional, gastrointestinal, and liver disorders. Researchers want to examine and treat people with digestive disorders in order to learn more about these disorders. They also want to study how digestive disorders run in some families. To do so, they will provide standard care to people with digestive disorders. They will also look at relatives of people with digestive disorders, such as parents, children, and siblings.

Objectives:

• To examine and treat people with digestive disorders.
• To evaluate people with digestive disorders for research studies.

Eligibility:

• Individuals of any age who have digestive disorders.
• Individuals at least 2 years of age who are first-degree relatives of the people with digestive disorders.

Design:

• Participants will have at least one outpatient visit to the National Institutes of Health. The visit will last about 2 hours.
• All participants will be screened with a physical exam and medical history. They will also provide different samples for study. Samples may include blood, urine, and stool samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may be collected from adult participants.
• Participants with digestive disorders may be able to receive treatment through this study.

Detailed Description

The National Institute of Nursing Research (NINR) is conducting a protocol to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed digestive conditions. Investigators of this protocol provide GI consultation at the NIH Clinical Center for a range of GI conditions.

Objectives: The primary objective of this protocol is to allow digestive care specialists in NINR and other institutions to provide standard of care. Evaluating and treating participants will allow digestive care specialists to maintain their expertise and gain additional knowledge of the course of various digestive disorders. Additionally this protocol will allow for hypothesis generation and provide a resource of patients for enrollment into new research protocols throughout the NINR branches. The information obtained will allow for the evaluation of standard treatments of the studied digestive diseases. This understanding may lead to ideas for future protocols. The protocol will also allow for trainees to receive training in the management of digestive disorders.

Study Population: The number of participants for this evaluation and treatment protocol will be set to 500 patients with digestive disorders and their unaffected first-degree relatives.

Design: This is a natural history evaluation and treatment protocol of the progression and physiology of multiple digestive disorders. Blood or other biologic samples (including but not limited to stool, urine, saliva, hair, cheek swab, or tissue) will be obtained through non-invasive means or incidentally to clinical care for future laboratory studies. In addition, genetic samples may be collected from unaffected first-degree relatives and may be used to identify and verify causative mutations.

Outcome Measures: The outcome measures for this protocol are the clinical assessments of enrolled participants, including their response to standard treatments. Also, causative mutations may help establish pathogenic mechanisms and genotype-phenotype correlations.

Conditions

Stress; Irritable Bowel Syndrome; Obesity; Abdominal Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Standard of Care. Participants will be evaluated and treated for their particular digestive disorder or presenting symptoms.

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Any evaluation or treatment under this protocol will be based on standard practice as related to the subjects's digestive disorder.These include but are not limited to biobehavioral interventions including bowel retraining, biofeedback, and other lifestyle interventions, all of which have been shown to be beneficial in the treatment of this type of chronic functional bowel disorder.

Interventions

Standard of Care

Any evaluation or treatment under this protocol will be based on standard practice as related to the subjects's digestive disorder.These include but are not limited to biobehavioral interventions including bowel retraining, biofeedback, and other lifestyle interventions, all of which have been shown to be beneficial in the treatment of this type of chronic functional bowel disorder.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

This protocol will include participants from birth and has no upper age limit.

Participants will be eligible if they:

1. Have either a digestive disorder, OR

2. Are an unaffected first-degree relative ( >2 years old) of a participant with a digestive disorder.

Exclusion Criteria

Participants will not be eligible if they:

1. Are unwilling to give informed consent or, if a minor, do not have a parent or guardian able to provide consent, cannot assign a Durable Power of Attorney (DPA) or if a minor, do not have a parent or guardian able to provide consent.

2. Have a systemic disease that, in the judgment of the investigators, compromises the ability to obtain research data.

3. NINR employees, subordinates/relatives/ or co-workers

4. Any NIH employess who is a subordinate/relative/or co-worker of a study investigator

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy A Henderson, C.R.N.P.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Nursing Research (NINR)

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

12-NR-0195

Identifier Type: -

Identifier Source: secondary_id

120195

Identifier Type: -

Identifier Source: org_study_id